Metabolic Responses After 12-week Hypocaloric Diet Supplemented With a Cereal-based Plant Protein Biscuit

Not Applicable

Completed

• Conditions: Appetite
• Interventions: Other: wheat biscuit enriched with plant proteins; Other: common wheat biscuit

• Registration Number: NCT05213559
• Lead Sponsor: Harokopio University

Brief Summary

Biscuits enjoy high popularity in the human diet and can be excellent snack alternatives and potential carriers of ingredients with appetite regulating properties. In the present study, the effects of a wheat biscuit enriched with plant proteins originated from legumes and seeds on gastrointestinal hormone responses of women with overweight/obesity after a hypocaloric dietary intervention will be examined.

Detailed Description

Women with overweight/obesity will follow a 12-week dietary intervention supplemented with a cereal-based biscuit enriched with plant proteins or a common isocaloric wheat biscuit as a daily snack.

At the beginning and at the end of the dietary intervention postprandial metabolic responses, body weight reduction and subjective appetite ratings will be examined.

Study Timeline

• Study First Submitted: 2022-01-20
• Study First Submitted QC: 2022-01-20
• Study First Posted: 2022-01-28
• Study Start: 2022-02-01
• Primary Completion: 2023-04-30
• Study Completion: 2023-08-30
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-26
• Last Update Posted: 2023-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

• non-diabetic women with overweight/obesity
• constant body weight for the last three months before enrollment
• standard dietary and physical activity habits

Exclusion Criteria

• pregnancy
• lactation
• chronic medical illness
• use of nutritional supplements
• alcohol consumption >2 drinks per day

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
wheat-based biscuit enriched with plant proteins	wheat biscuit enriched with plant proteins	Subjects follow a hypocaloric dietary intervention supplemented with certain amount of wheat-based biscuits enriched with plant proteins daily.
wheat biscuit	common wheat biscuit	Subjects follow a hypocaloric dietary intervention supplemented with certain isocaloric amount of common wheat biscuits daily.

Primary Outcome Measures

Name	Time	Method
change in postprandial glucose response	Time points: 0,30,60,91,120,180 min postprandially at week 0 and week 12.	change in glucose iAUC and glucose concentration at certain time points at the end of the dietary intervention compared to the beginning.

Secondary Outcome Measures

Name	Time	Method
change in postprandial appetite regulating hormone responses	Time points: 0,30,60,91,120,180 min postprandially at week 0 and week 12.	changes in iAUCs and concentrations at certain time points at the end of the dietary intervention compared to the beginning.

Trial Locations

Locations (1)

Laiko General Hospital, School of Medicine, National and Kapodistrian University of Athens; 🇬🇷 Athens, Attiki, Greece